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ZOLL Announces Acquisition of the Assets of CoAxia

July 1, 2013 11:19 am | by Business Wire | News | Comments

ZOLL Medical Corporation has purchased the assets of CoAxia, an early revenue stage medical device company that provides catheter-based perfusion augmentation therapies to improve outcomes for patients with cerebral ischemia resulting from vasospasm, following subarachnoid hemorrhage.

Poland - a New Player in Medical Tourism Sector

June 28, 2013 9:00 am | by PR Newswire | News | Comments

Is it possible, that in 2-3 years Brits, Germans, Scandinavians, and Russians will undergo cancer treatment, orthopaedic, or cardiac surgery procedures in Polish medical facilities more often? Treat teeth and get implants in dental clinics; take a cure in Polish sanatoriums?

New Red Blood Cell Simulator Invented At Queen Mary

June 27, 2013 3:58 pm | by Queen Mary, University of London | News | Comments

Engineers from Queen Mary, University of London have developed the most precise computer simulation of how red blood cells might travel around the body to help doctors treat people with serious circulatory problems. Understanding how damaged red blood cells might interact with each other or their neighboring cells could be useful in realizing blood flow in patients who are diabetic or have had surgery to address circulation complications.

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Device Designed to Avert Repeated Breast Cancer Surgeries

June 27, 2013 12:15 pm | by Johns Hopkins | Videos | Comments

When a breast tumor is detected, many women opt to have a lumpectomy, which is surgery designed to remove the diseased tissue while preserving the breast. But during this procedure, doctors cannot learn right away whether all of the cancerous tissue has been removed, with no microscopic signs that cancer cells were left behind.

Johns Hopkins Students’ Device Aims to Avert Repeated Breast Cancer Surgeries

June 27, 2013 11:57 am | by Johns Hopkins | News | Comments

To reduce the need for second surgeries, four Johns Hopkins graduate students have designed a device to allow pathologists to quickly inspect excised breast tissue within 20 minutes, while the patient is still in the operating room. If this inspection indicates that the tumor was not fully removed, additional tissue can then be removed during the same operation.

Spinning Up Antibacterial Silver on Glass

June 27, 2013 10:30 am | by Inderscience Publishers | News | Comments

The antibacterial effects of silver are well established. Now, researchers at Yonsei University in Seoul, Republic of Korea, have developed a technique to coat glass with a layer of silver ions that can prevent growth of pathogenic bacteria including Escherichia coli, Salmonella typhimurium and Campylobacter jejuni. The technology could be used to protect medical equipment.

Robotic Surgical Systems on the Ropes

June 26, 2013 2:16 pm | by Sean Fenske, Editor-in-Chief, MDT | Blogs | Comments

There have been reports of issues and lawsuits from procedures gone wrong when a robotic surgical system was used. Yes, there have been issues and they do need to be addressed, however, abandoning robotic surgical systems is not the answer. In fact, it would be a complete mistake.

PMA Final Decisions for April 2013

June 26, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

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CryoLife Receives Conditional IDE Approval to Begin Clinical Trials for PerClot@ in the U.S.

June 21, 2013 8:34 am | by The Associated Press | News | Comments

CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced today that it has received conditional approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration (FDA).

Class I Medical Device Recall: Medtronic Xomed, Inc., NIM Trivantage EMG Endotracheal Tube

June 21, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The firm received complaints of "cuff leak" or "cuff deflation" occurring when the inflation valve cap is inappropriately removed (pulled off, instead of snapped-off sideways). This requires the physician to re-inflate or replace the deflated tube to ensure the continued breathing support of the patient. Use of this recalled product can result in serious adverse health consequences, including death.

FDA Approves New Silicone Breast Implant from J&J

June 20, 2013 4:53 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

The Food and Drug Administration said last Friday it approved a next-generation silicone breast implant from Johnson & Johnson unit Mentor. The company's MemoryShape breast implant uses a cross-linking gel design that the FDA says is firmer than previous implants.

Realistic 3D Tumour Through Tissue Engineering Using Silk Scaffolds

June 20, 2013 9:47 am | by National University of Singapore | News | Comments

A team of NUS researchers from the Departments of Bioengineering and Orthopaedic Surgery has developed a highly realistic three-dimensional (3D) tumour model. As it replicates the conditions in the body, it is able to track the effectiveness and progress of drug therapy.

Medtronic Slips After Infuse Reviews Detailed

June 19, 2013 1:23 pm | by The Associated Press | News | Comments

Shares of Medtronic slipped Tuesday, a day after the medical device maker announced findings from independent reviews of studies of its Infuse bone graft. The Minneapolis company said the reviews, conducted through Yale University, concluded that clinical success rates with its Infuse product were equivalent to more traditional bone graft procedures in which bone is taken from the hip.

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Intelligent Door Seal Prevents Poor Air Quality

June 19, 2013 1:17 pm | by Fraunhofer | News | Comments

For a long time, heat insulation was en vogue – and nearly no one was concerned about poor indoor air quality. And yet excess CO2 hampers concentration. Now, researchers have come up with an intelligent door seal system.     

VERASENSE Knee System with Limb Alignment Receives FDA Clearance

June 19, 2013 9:43 am | by OrthoSensor | News | Comments

OrthoSensor has announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VERASENSE Knee System with limb alignment. VERASENSE is the first intraoperative instrument system to combine quantifiable data on limb alignment, implant position and soft tissue balancing for surgeons during total knee replacement surgery.

Critical Seconds Saved During Brain Aneurysm Procedure with Pre-Surgery Rehearsal

June 19, 2013 9:33 am | by Surgical Theater | News | Comments

Surgical Theater’s Surgical Rehearsal Platform (SRP) provided neurosurgeons the opportunity to rehearse a complicated cerebral case before entering the operating room, saving the surgical team critical seconds on a time-sensitive procedure.

New Surgery Alternative Removes Suspicious Polyps, Keeps Colon Intact

June 17, 2013 12:54 pm | by Rachel Champeau, University of California, Los Angeles Health Sciences | News | Comments

Millions of people each year have polyps successfully removed during colonoscopies. But when a suspicious polyp is bigger than a marble or in a hard-to-reach location, patients are referred for surgery to remove a portion of their colon — even if doctors aren't sure whether the polyp is cancerous or not.

Codman Neuro Obtains CE Mark for Thrombectomy Device

June 13, 2013 4:33 pm | by Codman Neuro | News | Comments

Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, has obtained CE marking for REVIVE SE, a next-generation self-expanding clot removal device for use in treating acute ischemic stroke, the company announced today at the Live Interventional Neuroradiology & Neurosurgery Course (LINNC) in Paris.

The Pulse: New Interface Rewires Nerves from Amputated Limbs

June 13, 2013 9:43 am | by Eric Sorensen, Coordinator of Multimedia Development | Videos | Comments

On this episode of The Pulse, rewired nerves from amputated limbs allow for prosthetic control with existing muscles, a bioengineered blood vessel is transplanted, diabetes is diagnosed through breath analysis alone, and a new technology is paving the way for low-cost electronic devices that work in direct contact with living tissue inside the body.

Study Assesses Impact of Rheumatoid Arthritis on Joint Replacement Surgery Outcomes

June 12, 2013 10:56 am | by Hospital for Special Surgery | News | Comments

Two new studies by researchers at Hospital for Special Surgery have shed light on joint replacement outcomes in patients with rheumatoid arthritis (RA). One study overturns the common belief that RA patients have worse outcomes after a total knee replacement (TKR) than patients who undergo the operation for osteoarthritis.

Approval Of Boston Scientific's Watchman Device Will Support Rapid Growth In The Global Heart Defect Closure Device Market

June 12, 2013 8:00 am | by The Associated Press | News | Comments

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the anticipated Food and Drug Administration (FDA) approval of Boston Scientific's WATCHMAN device will drive rapid growth in the market for global heart defect closure devices. ...

RTI Biologics Announces Agreement to Acquire Pioneer Surgical Technology

June 12, 2013 7:00 am | by Business Wire | News | Comments

RTI Biologics Inc., a leading provider of orthopedic and other biologic implants, announced today its intent to acquire privately held Pioneer® Surgical Technology (Pioneer), headquartered in Marquette, Mich. Pioneer is a leading medical technology company that manufactures and distributes metal and synthetic products in the orthopedics, biologics, spine, trauma and cardiothoracic markets.

Class I Medical Device Recall: Symbios GOPump and GOBlock Kits

June 12, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness...

Medical Specialties Distributors Acquires Medical Technology Resources

June 10, 2013 11:14 am | by PR Newswire | News | Comments

Medical Specialties Distributors, LLC ("MSD"), the nation's leading alternate-site infusion therapy solutions provider, announced today that it has acquired Medical Technology Resources, LLC ("MTR").  Headquartered in Columbus, Ohio, MTR specializes in providing infusion pumps and related products, as well as biomedical and billing services to alternate-site health care providers.  

Judge's Ruling Challenges U.S. Transplant System

June 10, 2013 9:45 am | by Lauran Neergaard, AP Medical Writer | News | Comments

It's a life or death matter: Who gets the next scarce donated organ? In an unprecedented challenge to the nation's transplant system, a federal judge has allowed one dying child — and a day later another — to essentially jump the line in rulings that could have ramifications for thousands of people awaiting new organs.

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